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Age Gene/Environment Susceptibility Reykjavik Study (AGES)

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ClinicalTrials.gov Identifier: NCT03269656
Recruitment Status : Completed
First Posted : September 1, 2017
Last Update Posted : September 1, 2017
Sponsor:
Collaborator:
University of Iceland
Information provided by (Responsible Party):
Icelandic Heart Association

Brief Summary:
5764 men and women in Iceland, aged 66 to 96 years entered the Ages Gene/Environment Susceptibility (AGES) - Reykjavik Study. Serum 25(OH)D was measured in 5,519 of all 5,764 (96%) participants at study entry in year 2002 through 2006. The main emphasis was on exploring whether pre-diagnostic serum levels of 25(OH)D were associated with survival after cancer diagnosis.

Condition or disease
Neoplasms

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Study Type : Observational
Actual Enrollment : 5764 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Association of Pre-diagnostic Vitamin D Levels and Survival in Older Individuals With Cancer
Actual Study Start Date : January 1, 2002
Actual Primary Completion Date : January 31, 2006
Actual Study Completion Date : December 31, 2014

Group/Cohort
AGES-Reykjavik participants
Exploring whether pre-diagnostic serum levels of 25(OH)D among older individuals living in Iceland were associated with survival after cancer diagnosis. We also assessed the risk of being diagnosed with cancer in association with 25(OH)D levels.



Primary Outcome Measures :
  1. Overall survival [ Time Frame: From date of diagnosis until death or censored at end of the follow-up (December 31, 2014) ]
    The association between pre-diagnostic 25(OH)D levels in cancer patients and overall survival

  2. Cancer survival [ Time Frame: From date of diagnosis until cancer death or censored at the end of the follow-up (December 31, 2014) ]
    The association between pre-diagnostic 25(OH)D levels in cancer patients and cancer survival


Secondary Outcome Measures :
  1. Cancer diagnosis [ Time Frame: From date of blood draw (study entry) until cancer diagnosis, death or end of the observation period (December 31, 2014) whichever occurred first ]
    The association between pre-diagnostic 25(OH)D levels and cancer risk


Biospecimen Retention:   Samples With DNA
Serum samples


Information from the National Library of Medicine

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Ages Eligible for Study:   66 Years to 98 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
In 1967, all 30,795 men and women living in the capital area of Iceland and born between 1907 and 1935 were invited by the Icelandic Heart Association to join a prospective cohort study. Approximately 19,000 attended the clinic at least once and became participants of the Reykjavik Study. Subsequently, in 2002, a random sample of the cohort comprising 5,764 men and women who were still alive in Iceland and aged 66 to 96 years entered the Ages Gene/Environment Susceptibility (AGES) - Reykjavik Study
Criteria

Inclusion Criteria:

  • To participate in the AGES-Reykjavik study

Exclusion Criteria:

  • To be diagnosed with cancer before study entry

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03269656


Sponsors and Collaborators
Icelandic Heart Association
University of Iceland
Investigators
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Principal Investigator: Johanna Torfadottir, PhD University of Iceland

Additional Information:
Publications:
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Responsible Party: Icelandic Heart Association
ClinicalTrials.gov Identifier: NCT03269656     History of Changes
Other Study ID Numbers: IHA
NO1-AG-1-2100 ( Other Grant/Funding Number: National Institute on Aging )
ZIAEY000401 ( U.S. NIH Grant/Contract )
First Posted: September 1, 2017    Key Record Dates
Last Update Posted: September 1, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Icelandic Heart Association:
Vitamin D
Cancer
Survival

Additional relevant MeSH terms:
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Vitamin D
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents